Definition of a Cosmetic

Across the world, laws and regulations are in place regarding the manufacture of cosmetics, their safety and use, as well as defining what constitutes a cosmetic. While much legislation does overlap, there is no global standard and rules do vary from country to country.

How a Cosmetic is Defined

Most countries have a distinction between what constitutes a cosmetic, a drug and a food, and how a product is defined depends on three main things:

What is the product’s purpose?

Where and how is it used?

What is it made of?

Certain products can be classed as a cosmetic in some countries, and as a drug in others. For example, sunscreen is classed as a cosmetic in New Zealand and the EU, but as a drug in USA.

The term “cosmeceutical” is not recognised as a category of product – it is a purely a marketing or consumer term, but not a legally recognised one.

Who Does The Legislation Apply To?

Anyone who imports, manufacturers and/or sells anything covered by the relevant cosmetic legislation in that country. So if you are making your own products, then you must know and adhere to the laws governing the manufacture and selling of cosmetics in the countries where you both make and sell.

Australia

Definition of a Cosmetic

The definition of cosmetics in Australia is similar to that of the EU and USA, i.e. a substance intended to contact with any external part of the human body, including the mucous membranes of the oral cavity and teeth, in order to clean, to change the appearance of, and to alter odour.

Main Legislation

Ingredients in cosmetic products, even those described as ‘natural’, are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act).

There is also the Cosmetic Standards 2007 – the national standards for cosmetics imported into, or manufactured in Australia and the Australian Government enforces those standards.

Canada

Definition of a Cosmetic

Section 2 of the Food and Drugs Act defines a cosmetic as:

Any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.

Main Legislation

In Canada, personal care products are regulated under the Food and Drugs Act. Personal care products can also fall into one of three categories: cosmetic, drugs or natural health products – all of which are covered by their own set of regulations under the Food and Drug Act.

European Union and EEA

Definition of a Cosmetic

In the European Union (EU), The Cosmetic Directive (1976) defines a cosmetic as:

A “cosmetic product” shall mean any substance or mixture intended to be places in contact with the various external parts of the human body (epidermis, hair system, nails, lip and external genital organs) or with the teeth and the mucous membranes of the oral cavity wit a view to exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or penetrating them or keeping them in good condition.

Many everyday products bought in chemists and department stores and used regularly by us may be thought of as a cosmetic, as it fulfills cosmetic requirements as defined above e.g it refreshes or protects. However, if a product also makes medical claims, it is not legally classed as a cosmetic and is covered by different laws.

Take hand wash for example – if the hand wash simply washes off dirt and refreshes, it is a cosmetic; however, if the hand wash also claims to kill bacteria, it is a medicine. To the average consumer, both hand washes would be viewed as cosmetic products, but in the eyes of EU law, only one is defined as a cosmetic.

Main Legislation

The EU Cosmetics Directive (76/768/EEC) is the main EU law on the safety of cosmetics. It is also applicable in the European Economic Area (EEA). In the UK, the directive is enacted as the Cosmetic Product (Safety) Regulations 2008.

The Cosmetics Directive covers many aspects of a cosmetic, including:

Listing substances that are banned from cosmetic use, restricted or only allowed under certain conditions (e.g. subject to warning labels).

Production using good manufacturing processes, from analysis to safety assessments of ingredients.

The presentation of a cosmetic e.g. appearance, packaging and labelling.

Uniform labelling, including ingredients, weight/volume, precise instructions of use if needed and durability (e.g. use by date).

Accurate marketing of cosmetics to prevent false claims being made.

Ensuring traceability of a cosmetic throughout the whole supply chain.

Taking measures against counterfeit products.

Many of the above aspects have their own specific regulation.

Japan

Main Legislation

The Standards for Cosmetics mainly covers ingredients permitted and prohibited from cosmetics.

New Zealand

Main Legislation

In New Zealand, the Environmental Protection Authority sets the rules for cosmetics and all similar products. The rules are contained in the Cosmetic Products Group Standard. This came into force in 2006 and is based on the EU regulations.

Included in this definition are products such as skin moisturisers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colours, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Main Legislation

Cosmetics are overseen by the Food and Drug Administration (FDA) and there are various laws and regulations that deal with different aspects of cosmetics, from labelling and ingredients to marketing and nanotechnology.

Under the FD&C Act, cosmetic products and ingredients, with the exception of colour additives, do not require FDA approval before they go on the market.

International

The International Organization for Standardization (ISO) publishes guidelines on the safe manufacturing of cosmetic products under a Good Manufacturing Practices (GMP) standard – ISO 22716:2007.

Regulators in several countries and regions have adopted this standard, effectively replacing existing guidance and standards.

ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetics.